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Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01334151
First Posted: April 13, 2011
Last Update Posted: July 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biodel
  Purpose
The primary objective of this study is to assess the speed of absorption and onset of action of BIOD-105 and BIOD-107 and compare them to Humalog®.

Condition Intervention Phase
Diabetes Mellitus Type 1 Drug: Insulin LISPRO Drug: recombinant human insulin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration

Resource links provided by NLM:


Further study details as provided by Biodel:

Primary Outcome Measures:
  • Speed of absorption [ Time Frame: 480 minutes ]
    The speed of absorption will be assessed by the time to reach 50% of maximum insulin concentration (TINS-50%-early, time before CINS max) and the onset of action will be assessed by the time to reach 50% of the maximum glucose infusion rate (TGIR-50%- early).


Enrollment: 13
Study Start Date: March 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Humalog®
Humalog®, administered subcutaneously on 1 occasion
Drug: Insulin LISPRO
Single doses of: 0.15 U/kg
Experimental: BIOD- 105
BIOD- 105 administered subcutaneously on 1 occasion
Drug: recombinant human insulin
Single doses of: 0.15 U/kg
Experimental: BIOD-107
BIOD-107 administered subcutaneously on 1 occasion
Drug: recombinant human insulin
Single doses of: 0.15 U/kg

Detailed Description:
The secondary objectives of this study are to assess other pharmacokinetic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, to assess other pharmacodynamic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-105 and BIOD-107 compared to Humalog®.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must present with the following:

  1. Body Mass Index: ≥ 18 - ≤ 28 kg/m2
  2. Diagnosed with type 1 diabetes mellitus for at least 1 year
  3. Insulin antibody less than or equal to 10 μU/mL at screening

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

  1. Type 2 diabetes mellitus
  2. Serum C-peptide > 1.0 ng/mL
  3. HbA1c > 10.0%
  4. History of hypersensitivity to any of the components in the study medication
  5. Treatment with any other investigational drug in the last 30 days before screening visit
  6. Regular smoking as assessed clinically by the Investigator.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01334151


Locations
United States, California
Profil Institute for Clinical Research, Inc. (PICR)
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Biodel
Investigators
Principal Investigator: Linda Morrow, MD Profil Institute for Clinical Research, Inc. (PICR)
  More Information

Responsible Party: Biodel
ClinicalTrials.gov Identifier: NCT01334151     History of Changes
Other Study ID Numbers: VIAject 039J
First Submitted: April 11, 2011
First Posted: April 13, 2011
Last Update Posted: July 26, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs